- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02513862
Prospective Trial of Autologous Platelet Rich Plasma in Aortic Surgery
November 15, 2016 updated by: Hongwen Ji
Prospective Randomized Trial of Autologous Platelet Rich Plasma in Reducing Allogeneic Transfusions During Aortic Surgery Under Deep Hypothermic Circulatory Arrest
The purpose of this study is to determine whether autologous platelet rich plasma (APRP)is effective in reducing allogeneic blood transfusions during aortic surgery using deep hypothermic circulatory arrest.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100037
- Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients undergoing elective or emergency aortic surgery using deep hypothermic circulatory arrest、
- preoperative platelet counts>150000000000/L、
- preoperative hematocrit>33%、
- without recent anticoagulants less than 5 days
Exclusion Criteria:
- preoperative coagulation disorder
- severe renal and liver dysfunction
- preoperative hemodynamic instability
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: APRP group
APRP group is performed autologous platelet-rich plasma harvest technique before administration of heparin to the patient,the red blood cell(RBC) component is retransfused to the patient when the RBC transfusion protocol is reached,and the autologous platelet-rich plasma is transfused to the patient immediately after heparin is neutralized with protamine.
|
15 to 20 mL/kg of whole blood is collected before the administration of heparin from a large-bore central venous access,and is separated into red blood cells component and autologous platelet-rich plasma component by an autologous transfusion system(Sorin Group Electa Essential; Sorin Group Italia, Milan, Italy).
Other Names:
|
No Intervention: control group
APRP group receive no autologous platelet-rich plasma harvest technique.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
total perioperative allogenic transfusions of platelet and fresh frozen plasma
Time Frame: on the 7th day postoperatively
|
on the 7th day postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
postoperative blood loss
Time Frame: on the 7th day postoperatively
|
on the 7th day postoperatively
|
rate of reexploration for bleeding
Time Frame: on the 7th day postoperatively
|
on the 7th day postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yongyuan Wang, Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
October 1, 2016
Study Registration Dates
First Submitted
June 23, 2015
First Submitted That Met QC Criteria
July 30, 2015
First Posted (Estimate)
August 3, 2015
Study Record Updates
Last Update Posted (Estimate)
November 16, 2016
Last Update Submitted That Met QC Criteria
November 15, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-zx011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on C.Surgical Procedure; Cardiac
-
Erasme University HospitalJean Paul Van VoorenUnknown
-
University Hospital, CaenCompletedHemodynamic Monitoring, Positive Inotropic and Vasoactive Drugs During Cardiac Surgery (EMOA) (EMOA)C.Surgical Procedure; CardiacFrance
-
University of Sao Paulo General HospitalInCor Heart Institute; Chinese Academy of Medical Sciences, Fuwai Hospital; Beneficência... and other collaboratorsUnknownC.Surgical Procedure; CardiacBrazil
-
Hongwen JiCompleted
-
Seoul National University HospitalSMG-SNU Boramae Medical CenterCompletedC.Surgical Procedure; CardiacKorea, Republic of
-
Helsinki University Central HospitalCompleted
-
Unity Health TorontoUnknownC.Surgical Procedure; CardiacCanada
-
Arkansas Children's Hospital Research InstituteCompletedC.Surgical Procedure; CardiacUnited States
-
Instituto do CoracaoUnknownC.Surgical Procedure; Cardiac | Heart; Dysfunction Postoperative, Cardiac SurgeryBrazil
-
IRCCS San Raffaele RomaEttore Sansavini Health Science FoundationCompletedC.Surgical Procedure; CardiacItaly
Clinical Trials on Autologous Platelet-Rich Plasma Harvest Technique
-
Rajavithi HospitalRecruitingAutologous Platelet-rich Plasma Supplement | Sperm Cryopreservation | Post-cryopreserved Sperm Quality | Semen AnalysisThailand
-
Genesis Athens ClinicNational and Kapodistrian University of AthensRecruitingMenopause, Premature | Menopausal Syndrome | Premature Ovarian Failure | Ovarian Failure, Premature | Menopause Related ConditionsGreece
-
Assiut UniversityUnknownAutologous Platelet Rich Plasma Effect on Bone Healing
-
Mayo ClinicCompleted
-
Center for Vulvovaginal DisordersCompletedLichen Sclerosus
-
Matthew GettmanCompleted
-
Sixth Affiliated Hospital, Sun Yat-sen UniversityRecruiting
-
Santiste Medical Inc.Recruiting
-
University of Colorado, DenverCompletedPlatelet-Rich PlasmaUnited States
-
Genesis Athens ClinicNational and Kapodistrian University of AthensRecruitingInfertility, Female | Perimenopausal Disorder | Menstrual Cycle AbnormalGreece